Opioid-Free Pain Management for Postoperative Pain
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Northwell Health
Must not be taking: Illicit substances, Gabapentin
Disqualifiers: Pregnancy, Renal disease, Seizure disorder, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This is a double-arm randomized control trial evaluating the impact of preoperative opioid-free analgesia on time to trial of void in ambulatory urogynecologic surgeries. The investigators hypothesize that receipt of acetaminophen, celecoxib and gabapentin preoperatively versus acetaminophen alone will reduce the time to trial of void in patients undergoing same-day minor urogynecologic procedures.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are currently using gabapentin at home, you cannot participate in the trial.
What data supports the effectiveness of the drug acetaminophen for opioid-free postoperative pain management?
Research shows that acetaminophen (also known as paracetamol) is effective for treating postsurgical pain and can reduce the need for opioids, which helps minimize opioid-related side effects. It is commonly used in pediatric postoperative pain management and has been shown to be safe and effective in various acute pain models.
12345Is opioid-free pain management using acetaminophen safe for postoperative pain?
Acetaminophen (also known as paracetamol) is generally considered safe for managing mild-to-moderate pain, including postoperative pain, when used at recommended doses. However, it may not provide sufficient pain relief on its own for some patients, and combining it with other medications like weak opioids can be a safer alternative to anti-inflammatory drugs, which have potential gastrointestinal and cardiovascular risks.
16789What makes the drug combination of Acetaminophen, Celecoxib, and Gabapentin unique for managing postoperative pain?
This drug combination is unique because it aims to manage postoperative pain without using opioids, which are commonly associated with risks of addiction and side effects. Acetaminophen and Celecoxib help reduce inflammation and pain, while Gabapentin is used for nerve-related pain, providing a comprehensive approach to pain management.
15101112Eligibility Criteria
This trial is for patients scheduled for same-day minor urogynecologic surgeries who can take medications like acetaminophen, celecoxib, and gabapentin. Specific eligibility criteria are not provided.Inclusion Criteria
In good general health as evidenced by medical history
I am willing and able to follow the study rules and attend all appointments.
Provision of signed and dated informed consent form
+3 more
Exclusion Criteria
I do not speak English or Spanish.
I am under 18 years old.
I have a serious heart condition.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Preoperative Treatment
Participants receive preoperative opioid-free analgesia with acetaminophen, celecoxib, and gabapentin or acetaminophen alone
Single day
1 visit (in-person)
Postoperative Monitoring
Participants are monitored for time to trial of void after surgery
1-2 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests if taking a combination of acetaminophen, celecoxib, and gabapentin before surgery helps patients recover bladder function faster than just acetaminophen alone. It's a randomized control trial with two groups.
2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care (SOC) (acetaminophen) and investigational product (celecoxib + gabapentin)Experimental Treatment3 Interventions
one time dose of 1000mg acetaminophen orally combined with 400mg celecoxib orally, and 300mg gabapentin orally
Group II: Standard of Care (SOC) (acetaminophen)Active Control1 Intervention
one time dose of 1000mg acetaminophen orally
Acetaminophen is already approved in United States, European Union, Canada, Australia for the following indications:
🇺🇸 Approved in United States as Tylenol for:
- Pain relief
- Fever reduction
🇪🇺 Approved in European Union as Paracetamol for:
- Pain relief
- Fever reduction
🇨🇦 Approved in Canada as Tylenol for:
- Pain relief
- Fever reduction
🇦🇺 Approved in Australia as Panadol for:
- Pain relief
- Fever reduction
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwell Health South Shore Surgery CenterBay Shore, NY
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Who Is Running the Clinical Trial?
Northwell HealthLead Sponsor
References
[Tonsillotomy and adenotonsillectomy in childhood. Study on postoperative pain therapy]. [2021]The primary aim of this study was to determine whether the combination of i.v. ketoprofen and i.v. paracetamol provides superior postoperative analgesia in children undergoing adenoidectomy or tonsillotomy compared to either drug alone. The secondary goal was to assess the time until rescue analgesia was needed, propofol requirements and the incidence of vomiting and time of discharge from the postanaesthesia recovery unit (PARU).
[Administration of paracetamol versus dipyrone by intravenous patient-controlled analgesia for postoperative pain relief in children after tonsillectomy]. [2015]We compared the efficacy of intravenous (IV) paracetamol versus dipyrone via patient-controlled analgesia (PCA) for postoperative pain relief in children.
Administration of paracetamol versus dipyrone by intravenous patient-controlled analgesia for postoperative pain relief in children after tonsillectomy. [2017]We compared the efficacy of intravenous (IV) paracetamol versus dipyrone via patient-controlled analgesia (PCA) for postoperative pain relief in children.
Continuous multimechanistic postoperative analgesia: a rationale for transitioning from intravenous acetaminophen and opioids to oral formulations. [2013]Good surgical outcomes depend in part on good pain relief, allowing for early mobilization, optimal recovery, and patient satisfaction. Postsurgical pain has multiple mechanisms, and multimechanistic approaches to postoperative analgesia are recommended and may be associated with improved pain relief, lowered opioid doses, and sometimes a lower rate of opioid-associated side effects. Acetaminophen (paracetamol) is a familiar agent for treating many types of pain, including postsurgical pain. Oral acetaminophen has been shown to be safe and effective in a variety of acute pain models. Combination products using a fixed-dose of acetaminophen and an opioid have also been effective in treating postsurgical pain. Combination products with acetaminophen have demonstrated an opioid-sparing effect, which inconsistently results in a reduced rate of opioid-associated side effects. Intravenous (IV) acetaminophen and an opioid analgesic administered in the perioperative period may be followed by an oral acetaminophen and opioid combination in the postoperative period. Transitioning from an IV acetaminophen and opioid formulation to a similar but oral formulation of the same drugs appears to be a reasonable step in that both analgesic therapies are known to be safe and effective. For postsurgical analgesia with any acetaminophen product, patient education is necessary to be sure that the patient does not concurrently take any over-the-counter products containing acetaminophen and accidentally exceed dose limits.
[Postoperative pain therapy in pediatrics. Results of a representative survey in Germany]. [2019]The last survey addressing postoperative pain management in Germany was published in 1987, special data concerning postoperative pain management in pediatric patients had not been presented previously. The goal of this survey is to present the standard of postoperative pain management in pediatric patients in Germany. A detailed questionnaire was mailed to all German anaesthesia departments and interdisciplinary intensive care units (n = 1,500) to determine the current management of postoperative pain management in pediatric patients. After eight weeks, 42.6% of the survey had been returned. Rectally administered acetaminophen is the standard drug regimen for postoperative analgesia in children. Compared to previous surveys, the use of opioids has increased in popularity. The routine use of non-steroid antiinflammatory drugs (NSAIDs) and spasmolytics as well as the application of regional anaesthesia techniques is uncommon in pediatric postoperative pain management. Compared to other European countries, patient- or parent-controlled analgesia is more popular in Germany. Despite modern concepts of organization and a great variety of drugs available today, 71.1% of the responding anesthesiologists in this survey still believe that pediatric postoperative pain management needs to be improved.
Comparative effect of paracetamol, NSAIDs or their combination in postoperative pain management: a qualitative review. [2022]Quantitative reviews of postoperative pain management have demonstrated that the number of patients needed to treat for one patient to achieve at least 50% pain relief (NNT) is 2.7 for ibuprofen (400 mg) and 4.6 for paracetamol (1000 mg), both compared with placebo. However, direct comparisons between paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs) have not been extensively reviewed. The aims of this review are (i) to compare the analgesic and adverse effects of paracetamol with those of other NSAIDs in postoperative pain, (ii) to compare the effects of combined paracetamol and NSAID with those of either drug alone, and (iii) to discuss whether the adverse effects of NSAIDs in short-term use are justified by their analgesic effects, compared with paracetamol.
Pain management today - what have we learned? [2022]Pain is a leading cause of morbidity worldwide, with published data showing its prevalence as high as 50% for chronic pain in the European population. This prevalence is likely to continue to rise, particularly in elderly people with comorbid conditions and complex aetiologies of pain. There is thus a rapidly growing demand for safe and effective pain management. Management of mild-to-moderate pain has traditionally been based upon the use of non-steroidal anti-inflammatory drugs (NSAIDs) and the synthetic non-opioid analgesic paracetamol (acetaminophen), the latter of which acts centrally, inhibiting brain cyclo-oxygenase (COX) and nitric oxide synthase. Both the NSAIDs and paracetamol are effective for mild-to-moderate pain and are widely recommended and used. However, NSAIDs may not be tolerated due to gastrointestinal (GI) symptoms and can result in potentially fatal peptic ulceration and bleeding. Selective COX-2 inhibitors were developed to reduce the GI side effects and complications, but large-scale studies have highlighted another serious potential effect of anti-inflammatory drugs: cardiovascular events. Both the European Medicines Agency (EMEA) and the Food and Drugs Administration (FDA) in the US have issued advice to apply cautions and restrictions when prescribing COX-2 inhibitors, particularly for patients at increased cardiovascular risk and for long-term use. The FDA also applied cardiovascular warnings with regard to nonselective NSAIDs. Both the EMEA and the FDA have recommended using the lowest effective dose for the shortest duration. These concerns and warnings have left physicians seeking safe alternatives to anti-inflammatory drugs for both short- and long-term uses in many patients. These developments have generated a climate of uncertainty in the absence of official guidance on the selection of alternative analgesic regimens. Amongst the possible strategies, combinations of drugs that provide analgesic efficacy at reduced individual doses may confer the optimal risk-benefit ratio for pain management in the long term or in patients at increased cardiovascular risk. Weak opioids devoid of serious organ-damaging effects combined with paracetamol may well be safer for long-term therapy. Fixed-dose combinations of paracetamol with weak opioids, such as codeine, dextropropoxyphene or tramadol are currently available. Paracetamol plus tramadol is an effective and safe multimodal analgesic regimen for the management of both acute and chronic moderate-to-severe pain. Re-evaluating the role of weak opioids, such as tramadol, and combinations in pain management may prove a valuable option for prescribers seeking alternatives to anti-inflammatory drugs.
Effective analgesic between acetominophen + B vitamins vs. acetominophen in pediatric ambulatory surgery. [2018]analgesics in pediatric ambulatory surgery must be safe and effective. Acetominophen is safe with moderate efficacy; therefore, we searched for other drugs. In preclinical trials, improved efficacy was reported with the combination of acetaminophen + B vitamins. The aim of this study was to determine the analgesic efficacy of acetaminophen + B vitamins in pediatric ambulatory surgery.
Examination of acetaminophen for outpatient management of postoperative pain in children. [2019]We have examined acetaminophen (paracetamol) dosing for outpatient management of posttonsillectomy pain in children. Forty children, 5-15 years of age, undergoing tonsillectomy and their parents were randomly assigned to use a scheduled administration of acetaminophen in weight appropriate doses, 60 mg.kg-1.24h-1 orally, 90 mg.kg-1.24h-1 rectally, or to use acetaminophen 'as needed' according to present standards (control group). Postoperative pain was assessed by the child using the poker chip tool for the first three days after discharge. The prevalence of pain amongst all the children was high. The second day after discharge 22%-64% of the children in the study group and 36%-73% of the children in the control group rated severe pain. Recommended dose ranges of acetaminophen do not provide sufficient pain relief in children following tonsillectomy. Further studies are required to determine, whether higher doses of acetaminophen or analgesics with different analgesic properties will lead to improved analgesia in children following tonsillectomy.
Evaluation of the Efficacy of Paracetamol in the Control of Pain After Adenotonsillectomy in the Pediatric Population. [2022]Introduction Adenotonsillectomy is a common surgical procedure in otolaryngology. Over the years, several techniques have been developed and modified in order to reduce mortality and morbidity. Postoperative pain control remains controversial. The aim of this study was to evaluate the efficacy of paracetamol alone in the control of postoperative pain. Methods A prospective study was conducted between May 2018 and February 2019, including 76 pediatric patients (age 0.05). The average intensity of postoperative pain was 3.36 and was higher in patients with infectious criteria as surgical indications (p
Postoperative analgesia with preoperative oral ibuprofen or acetaminophen in children undergoing myringotomy. [2019]Previous studies have shown over 70% of children require analgesics following bilateral myringotomy and tube placement (BM&T). This double-blind, placebo-controlled study compared the postoperative analgesic effects of preoperatively administered oral acetaminophen or ibuprofen. Forty three ASA I or II children age six months or older scheduled for elective BM&T were randomized to receive acetaminophen (paracetamol) 15 mg.kg-1, ibuprofen 10 mg.kg-1, or placebo. Postoperative pain was assessed using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) upon arrival to the PACU and at 5, 10, 15, 30, 45, and 60 min. CHEOP scores did not differ between the groups at any time. There was no difference in the number of children receiving rescue analgesia. This study showed no benefit of preoperatively administered oral ibuprofen 10 mg.kg-1 or acetaminophen 15 mg.kg-1 over placebo for the relief of postoperative pain in children undergoing BM&T.
Management of postsurgical pain in the community. [2021]Following surgery there is often a need for ongoing pain management after the patient is discharged from hospital. This can be made easier if the patient has an appropriate discussion before leaving hospital about what pain they can expect, and they are given a management plan Paracetamol and non-steroidal anti-inflammatory drugs are suitable for most patients. Drugs with a short half-life, such as ibuprofen, may need to be taken regularly Short-acting opioids can have a short-term role, providing guidelines are followed. There is a predictable period of time after surgery when the benefit of an opioid is expected to be maximised before harmful adverse effects will dominate Gabapentinoids are useful for neuropathic pain, but have a limited role in nociceptive pain. Like opioids, they have a risk of misuse The surgeon should be consulted if the patient develops new pain or the postoperative pain becomes more severe Most postsurgical pain will resolve within three months. If not, it is deemed persistent pain that may warrant specialist assessment